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FDA Acts on Acacia Rigidula Products

<p>The agency <a target="_blank">sent warning letters to five marketers </a>of dietary supplements containing the botanical <em>Acacia rigidula</em>, advising them this is a new dietary ingredient (NDI) for which there is insufficient data showing the ingredient is &ldquo;reasonably expected to be safe."</p>

Mar 15, 2016

FDA sent warning letters to five marketers of dietary supplements containing the botanical Acacia rigidula, advising them this is a new dietary ingredient (NDI) for which there is insufficient data showing the ingredient is “reasonably expected to be safe." FDA said it considers these supplements adulterated and told the recipients to immediately cease distribution of the supplements. The agency gave the letter recipients 15 days to respond with specific steps planned to correct the violations.

FDA has said A. rigidula was not marketed in the United States before October 1994, is not an approved food additive and is not generally recognized as safe (GRAS) for foods.

FDA reminded the companies that “the new dietary ingredient notification requirement applies to all dietary supplements that contain new dietary ingredients that have not been present in the food supply as articles used for food in a form in which the food has not been chemically altered." However, it further said an NDI notification for A. rigidula likely wouldn’t pass muster. “Even if the required notification had been submitted, we know of no evidence that would establish that your product is not adulterated," it wrote in the letters.

When contacted by INSIDER, Nubreed Nutrition said it reformulated UNDISPUTED six months ago, and the removal of A. rigidula has not changed the effectiveness of the product. INSIDER found some third party internet retailers still seemed to have the version with A.rigidula. “A recall of the old version is currently being conducted in the market," Nubreed told INSIDER.

At press time, the other four companies receiving warning letters had not responded to INSIDER’s request for comment.

This isn't the first time A. rigidula was on FDA's radar. The agency sent a handful of warning letters about a year ago to marketers of supplements containing BMPEA, advising them to stop the sale of the misbranded products immediately or face further enforcement action. Many of these offending products contained A. rigidula, which was purported to be the botanical source for BMPEA. However, researchers from FDA unable to find any evidence the botanical contained BMPEA. Interestingly, the BMPEA warning letters did not warn about the NDI status or legality of A.rigidula as a dietary ingredient.

The BMPEA warning letters came after a study from Harvard Medical School and the Netherlands National institute of Health and the Environment found scores of A.rigidula supplements were adulterated with synthetic BMPEA. This study prompted several Senators to urge FDA to act on BMPEA.

One of the recipients of last year’s BMPEA warning letters, Hi-Tech Pharmaceuticals, quickly sued the study’s lead researcher, Pieter Cohen, M.D., of Harvard Medical School and Cambridge Health Alliance, alleging the paper, as well as Cohen’s statements in the media, slandered Hi-Tech and caused harm to its business and reputation. Hi-Tech sought US$200 million for compensatory and punitive damages. The lawsuit was dismissed on April 9, 2016 by U.S. District (Atlanta) Judge Steve C. Jones, saying his court had no personal jurisdiction over Cohen and that the other researchers named as defendants had not been served with the complaint before the deadline passed to do so. Hi-Tech said it would refile the lawsuit in Massachusetts, where Cohen works and lives.

On the new A. rigidula warning letters, Duffy MacKay, N.D., senior vice president of scientific and regulatory affairs for the Council for Responsible Nutrition (CRN), said there is no excuse for companies to market an NDI without filing the proper notification with FDA. He also told INSIDER that while it is a positive sign to see FDA taking enforcement action against adulterated products, companies failing to submit NDI notifications and selling adulterated products should be held accountable and penalized. “Consumer safety is our first priority," he said, noting if there is any indication that consumer safety may be compromised, the agency has legal authority to take strong action beyond warning letters. “We urge FDA to act now, like we did a year ago, to get these products off the market."

MacKay also emphasized that rogue companies blatantly ignoring the law continue to tarnish the reputation of the dietary supplement industry." [This] underscores the importance of the responsible, mainstream industry coming together to create initiatives that help consumers avoid illegal products and help FDA identify bad actors."